Back to resultsEfficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
Primary Purpose
Acute Leukemic Patients in Children
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Acute Leukemic Patients in Children focused on measuring crossover; double blinded; intrathecal chemotherapy; dexamethasone; ketamine;vomiting
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 2-15 years who underlying acute lymphoid or nonlymphoid leukemia and need to receive ketamine and intrathecal chemotherapy.
- Personally signed and dated informed consent and assent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study entry.
Exclusion Criteria:
- Patients who had a known allergy to ketamine or dexamethasone.
- Patients who had contraindication for ketamine or dexemethasone such as hypertension, increased intracranial pressure or central nervous system mass lesion, major psychiatric , and hyperglycemia.
- Patients who concurrent with nausea and vomiting during that time.
- Patients who received ondansetron or other antiemetic before doing Procedure.
- Patients who received other chemotherapy before or after 24 hours.
Sites / Locations
- Phramongkutklao hospital
- Phramongkutklao Hospital
Outcomes
Primary Outcome Measures
: To determine whether vomiting and retching associated with intravenous ketamine and intrathecal chemotherapy may be reduced by the addition of prophylactic dexamethasone
Secondary Outcome Measures
To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01094990
Brief Title
Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
Official Title
Efficacy of Dexamethasone for The Prevention of Nausea and Vomiting Associated With Intrathecal Chemotherapy and Ketamine Sedation in Children With Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHANCHAI TRAIVAREE
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Null hypothesis The proportions of vomiting are not different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy
Detailed Description
Does intravenous dexamethasone 0.25 mg/kg (8 mg/m2/dose) have an effect in the reduction of vomiting and retching after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy comparison with placebo?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemic Patients in Children
Keywords
crossover; double blinded; intrathecal chemotherapy; dexamethasone; ketamine;vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time
Primary Outcome Measure Information:
Title
: To determine whether vomiting and retching associated with intravenous ketamine and intrathecal chemotherapy may be reduced by the addition of prophylactic dexamethasone
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged between 2-15 years who underlying acute lymphoid or nonlymphoid leukemia and need to receive ketamine and intrathecal chemotherapy.
Personally signed and dated informed consent and assent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study entry.
Exclusion Criteria:
Patients who had a known allergy to ketamine or dexamethasone.
Patients who had contraindication for ketamine or dexemethasone such as hypertension, increased intracranial pressure or central nervous system mass lesion, major psychiatric , and hyperglycemia.
Patients who concurrent with nausea and vomiting during that time.
Patients who received ondansetron or other antiemetic before doing Procedure.
Patients who received other chemotherapy before or after 24 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chanchai traivaree, MD
Organizational Affiliation
Phramongkutklao College of Medicine and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phramongkutklao hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
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